BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE 90-CM LENGTH PERCUTANEOUS LEAD

    MDR report key: 2160602 · Received July 6, 2011

    Report

    Report Number
    1627487-2011-03213
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT 1627487-2011-03245. THE PT RECEIVED A SCS SYSTEM ON (B)(6) 2010 INCLUDING TWO LEADS FROM DIFFERENT LOTS. IT WAS REPORTED THAT THE PT HAD CLAIMED THE STIMULATION DID NOT COVER ENTIRE PAIN AREA SINCE IMPLANTED. THE PHYSICIAN WANTED TO REPOSITION THE LEADS AND FOUND THE LEAD TO BE KINKED. THE PHYSICIAN REPLACED BOTH LEADS AND ANCHORS AND SUBSEQUENTLY RESOLVED THE PT'S ISSUE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 90-CM LENGTH PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3189 3097064

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SCS ANCHOR: MODEL 1192 (3)| IMPLANTED:| SCS IPG: MODEL 3788| IMPLANTED: